Theragen Lifesciences

Services

Pre-formulation Development

  1. Polymorph screening and selection
  2. Salt form selection
  3. pH solubility and solution stability
  4. Intrinsic dissolution rate
  5. pKa and Log P determination
  6. Excipient compatibility


Formulation Development
Formulation Development Team offers an unparalleled level of expertise to develop a wide range of Conventional and Specialized Dosage Forms including Novel Technological Solutions.

  1. Solid oral dosage Forms:

                  Tablets: IR, DR, SR, orally disintegrating, Bilayer tablets

                  Capsules: Hard gelatin and Soft gelatin

      2. Powder for Oral solutions.

      3. Liquid Oral Dosage Forms: Solution, Suspension and Emulsion

     

Analytical Development
Our Analytical team provides dedicated services and support to customers in all phases of Drug Product Development in compliance with cGMP and ICH guidelines. We work with Cross-Functional Project Teams to provide our clients with an Integrated Services.

  1. Analytical Method Development
  2. Analytical Method Validation
  3. Cleaning validation
  4. Analytical method transfer
  5. Multimedia dissolution profile


Global Regulatory Affairs and Outsourcing Services
Our Regulatory team is capable of providing Technical reviews and compiling Dossiers in formats like eCTD, ACTD for filing in USA, EU, APAC, CANADA, MENA, South Africa and LATAM as per Country specific submission procedures laid by respective Regulatory Authorities. 

Our Team provides a pragmatic approach, hands-on support to frame Global Regulatory Strategy, Regulatory Planning and assures a structured follow-up of the applications to enable faster approval and support Product Life-Cycle Management.


Theragen Lifesciences